Common use of JSC Responsibilities Clause in Contracts

JSC Responsibilities. The JSC’s activities shall include the following responsibilities with regard to the Diagnostic Test: (a) review, confirmation, modification and/or update of the Development Plan, the Regulatory Plan and the Commercialization Plan, subject to final approval by the Parties; (b) monitoring of the development, regulatory and commercialization activities under the Development Plan, the Regulatory Plan and Commercialization Plan, respectively; (c) resolution of issues raised by the Alliance Leads; (d) exchange of development and commercialization information; and (e) alignment of the regulatory submissions and Regulatory Approvals between any Epizyme Product and the Diagnostic Test. The JSC shall keep accurate and complete confidential minutes of its meetings. The Alliance Leads shall be responsible for taking such minutes and distributing them to the JSC members for their review and comment within [**] business days after the date of each meeting, and within [**] business days after the receipt thereof, the JSC members shall remit such minutes back to the Alliance Leads with their comments, if any. The JSC members shall in good faith attempt as quickly as is reasonably possible to resolve any disputes as to the content of such minutes so as to have a final agreed version as quickly as is reasonably possible. Each Party shall be responsible for all expenses incurred by its representatives on the JSC in connection with performing their duties hereunder, including all costs of travel, lodging and meals. For the avoidance of doubt, the JSC shall not have the authority to amend this Agreement, and shall have authority to amend the Development Plan, the Regulatory Plan and/or the Commercialization Plan only as expressly set forth herein, with the written consent of the Parties.

Appears in 2 contracts

Sources: Development and Commercialization Agreement (Epizyme, Inc.), Development and Commercialization Agreement (Epizyme, Inc.)

JSC Responsibilities. The JSC’s activities JSC shall include the following responsibilities with regard to the Diagnostic Test: be responsible for (a) review, confirmation, modification and/or update reviewing the progress of the Development and ensuring that the Development commences and proceeds according to the Development Plan, ; (b) coordinating the Regulatory Development and Commercialization activities under the Development Plan and the Commercialization Plan; (c) discussing and suggesting amendments to the Development Plan and Commercialization Plan to a higher decision level for both Parties; (d) exchanging information related to publication strategies and review of such information; (e) resolving issues or disagreements raised by the JCC, JPT or JPT Leads, subject to final approval by the Parties; ; (bf) monitoring facilitating the transfer of the information and data related to development, regulatory Commercialization and commercialization Regulatory Approval processes or other processes for completing activities under respecting the Development Plan, the Regulatory Plan and Commercialization Plan, respectively; ; (cg) resolution of issues raised by facilitating the Alliance Leads; (d) exchange of development and commercialization information; and (e) alignment cooperation of the regulatory submissions Parties, when requested, to provide information and Regulatory Approvals support; (h) facilitating coordinated interpretation of Clinical Data and other Data; (i) discussing freedom to operate aspects and issues; (j) coordinating planned marketing activities; and (k) such other activities pertaining to the Development and Commercialization activities ascribed to the JSC in this Agreement or as mutually agreed between the Parties from time to time (including the formation or disbandment of any Epizyme Product and subcommittees (e.g., the Diagnostic TestJPT or JCC). The JSC shall keep accurate and complete confidential minutes of its meetings. The Alliance Leads co-chairs for each meeting, or their respective designees, shall be responsible for taking such minutes and distributing them a coordinated single draft agreed upon by the co-chairs to the other JSC members for their review and comment within [***] business days Business Days after the date of each meeting, and within [**] business days after the receipt thereof, the JSC members shall remit such minutes back to the Alliance Leads with their comments, if any. The JSC members shall in good faith attempt as quickly as is reasonably possible to resolve any disputes as to the content of such minutes so as to have a final agreed version as quickly as is reasonably possible, but no later than [***] Business Days after the dispute is raised. Each Party of BTO and ▇▇▇▇▇▇▇ shall be responsible for all expenses incurred by its representatives on the JSC in connection with performing their duties hereunder, including all costs of travel, lodging and meals. For the avoidance of doubt, the JSC shall not have the authority to amend this Agreement, Agreement and shall have authority to amend the Development Plan, the Regulatory Plan and/or the and Commercialization Plan only as expressly set forth herein, or with the written consent of the Parties.

Appears in 2 contracts

Sources: Development and Commercialization Agreement (BillionToOne, Inc.), Development and Commercialization Agreement (BillionToOne, Inc.)

JSC Responsibilities. The JSC’s activities shall include the following responsibilities with regard to the Diagnostic TestTest for the Diagnostic Test Intended Use: (a) review, confirmation, modification and/or update of the Development Plan, the Regulatory Plan and the Commercialization Plan, subject to final approval by the Parties; (b) monitoring of the development, regulatory and commercialization activities under the Development Plan, the Regulatory Plan and Commercialization Plan, respectively; (c) resolution of issues raised by the Alliance LeadsProject Managers; (d) exchange of development and commercialization information; and (e) alignment of the regulatory submissions and Regulatory Approvals between any Epizyme Idera Product and the Diagnostic Test. The JSC shall keep accurate and complete confidential minutes of its meetings. The Alliance Leads co-chairpersons for each meeting, or their designee, shall be responsible for taking such minutes and distributing them to the other JSC members for their review and comment within [**] business days after the date of each meeting, and within [**] business days after the receipt thereof, the other JSC members shall remit such minutes back to the Alliance Leads Chairperson with their comments, if any. The JSC members shall in good faith attempt as quickly as is reasonably possible to resolve any disputes as to the content of such minutes so as to have a final agreed version as quickly as is reasonably possible. Each Party shall be responsible for all expenses incurred by its representatives on the JSC in connection with performing their duties hereunder, including all costs of travel, lodging and meals. For the avoidance of doubt, the JSC shall not have the authority to amend this Agreement, and shall have authority to amend the Development Plan, the Regulatory Plan and/or the Commercialization Plan only as expressly set forth herein, with the written consent of the Parties.

Appears in 1 contract

Sources: Development and Commercialization Agreement (Idera Pharmaceuticals, Inc.)